OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 (REF N3821744)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170434532), received between May 11, 2023 and Jul 22, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K221690); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE CYSTONEPHROFIBERSCOPE'S BENDING SECTION COVER ADHESIVE WAS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566586 ↗
• MalfunctionApr 15, 2024Flaked; Flaked

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE HAD BLACK COATING FLAKED OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105885 ↗
• MalfunctionNov 30, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE FIELD SERVICE TECHNICIAN WAS ON-SITE AT A CUSTOMER LOCATION AND FOUND THE CYSTONEPHROFIBERSCOPE NEEDED AN INSPECTION AND REPAIR. THE INSPECTION FOUND THE DISTAL END AND BIOPSY CHANNEL HAD FOREIGN MATERIAL ATTACHED. THERE WERE NO REPORTS OF PATIENT OR USER HARM OR PROCEDURE ASSOCIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243739 ↗
• MalfunctionNov 10, 2023Break; No Display/Image; Break; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE CYSTONEPHROFIBERSCOPE BENDING SECTION COVER WAS COMPLETELY BROKEN, THE SCOPE HAD A LEAK AND THE SCOPE HAD NO OPTIMAL VISUALIZATION. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115749 ↗
• MalfunctionNov 9, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES CYSTONEPHROFIBERSCOPE HAD AN IMAGE PROBLEM AND THE INSTRUMENT CHANNEL PORT WAS LOOSE. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107181 ↗
• MalfunctionAug 15, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS MEDICAL THAT THE OES CYSTONEPHROFIBERSCOPE WAS REPROCESSED WITHOUT THE ETO CAP ATTACHED AS PER DEVICE INSTRUCTIONS. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553573 ↗
• MalfunctionAug 1, 2023Microbial Contamination of Device; Microbial Contamination of Device

  AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE CUSTOMER THEN LEFT THE DEVICE TO THE OLYMPUS FRANCE (OFR) FRENCH OLYMPUS SUBSIDIARY FOR HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) FOR FURTHER INVESTIGATION. NO REPORT OF ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432992 ↗
• MalfunctionJul 28, 2023Device Reprocessing Problem; Device Reprocessing Problem

  AN OLYMPUS MEDICAL ENDOSCOPY SUPPORT SPECIALIST PERFORMED A SCOPE REPROCESSING IN-SERVICE AT THE CUSTOMER SITE AS PART OF ANNUAL TRAINING. DURING THE ANNUAL TRAINING, A STAFF MEMBER DEMONSTRATED REPROCESSING AND THE TECHNICIAN DID NOT FLUSH THE DEVICE WITH DETERGENT SOLUTION, WATER AND AIR AFTER THE BRUSH-CLEANING WAS COMPLETED. THE FLUSHING STEPS ARE OUTLINED IN THE DEVICE REPROCESSING MANUAL. THE DEVICE DELIVERED A BIOPSY CHANNEL DETACHMENT ERROR WHEN IT WAS BEING REPROCESSED IN THE DEVICE REPROCESSOR. THE ENDOSCOPY SUPPORT SPECIALIST INSTRUCTED THE TECHNICIAN THAT IF THE SCOPE WERE BEING STERILIZED, THE FLUSHING STEPS HAD TO BE PERFORMED. THE TECHNICIAN REPEATED THE DEMONSTRATION OF REPROCESSING WITH ALL REQUIRED STEPS PERFORMED. THE ISSUE WAS RESOLVED DURING OBSERVATION. ONCE THE FACILITY INPUTTED THE CORRECT MODEL NUMBER, THE ERROR WENT AWAY. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419869 ↗
• MalfunctionJul 6, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR UNEXPECTED CONTAMINATION. THE SCOPE WAS SAMPLED ONCE. DURING THE SAMPLING, THE SCOPE TESTED POSITIVE FOR < 1 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED AEROBIC MICROORGANISMS AND UNSPECIFIED ENTEROBACTERIA¿S. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17272628 ↗
• MalfunctionMay 11, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THAT THE OES CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING REGULAR EXAMINATION IN THE HOSPITAL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221690. One submission often covers many models, so check the product and lot details in each record.

• Z-0684-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-5, Cystonephrofiberscope
• Z-0685-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-5R, Cystonephrofiberscope
• Z-0331-2024 · Sep 25, 2023 · Open, Classified
  Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.